BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INTERSTIM II

    MDR report key: 3242342 · Received July 23, 2013

    Report

    Report Number
    3004209178-2013-12139
    Event Type
    Injury
    Date Received
    July 23, 2013
    Date of Event
    July 6, 2012
    Report Date
    June 26, 2013
    Manufacturer
    MEDTRONIC MED REL MEDTRONIC PUERTO RICO
    Product Code
    EZW
    PMA / PMN Number
    P970004
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT ID 3037 LOT# SERIAL# (B)(4), PRODUCT TYPE PROGRAMMER, PATIENT PRODUCT ID NEU_UNKNOWN_LEAD LOT# SERIAL# UNKNOWN, IMPLANTED: 2012 (B)(6), PRODUCT TYPE LEAD. (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED, THE PATIENT SAW THEIR HEALTHCARE PROFESSIONAL YESTERDAY AND THEY BELIEVED THE PATIENT MAY HAVE A BLADDER INFECTION. THE REPORTER STATED THEY HAVE HAD A BACTERIAL INFECTION IN THEIR BLADDER ¿ABOUT EVERY MONTH TO 2 MONTHS¿ SINCE HAVING THE IMPLANTABLE NEUROSTIMULATOR (INS) IMPLANTED. IT WAS NOTED, THE PATENT HAD BEEN TREATED IN THE PAST WITH ANTIBIOTICS AND WAS CURRENTLY TAKING METHENAMINE FOR THE LAST MONTH AND A HALF. IT WAS FURTHER NOTED, THE PATIENT WAS GIVEN A PRESCRIPTION FOR SUPRAX FOR A POSSIBLE BLADDER INFECTION. IT WAS NOTED, THE PATIENT HAD PAIN AT THE INS POCKET SITE ON THEIR RIGHT SIDE FROM 1PM TO 3PM ON THE DAY OF THIS REPORT. THE REPORTER STATED, SHE TALKED ON HER CELL PHONE AND USED EAR BUDS AND WAS CONCERNED THE CELL PHONE AND EAR BUDS MAY HAVE CAUSED HER PAIN. IT WAS NOTED, THE PATIENT¿S PAIN HAD ¿CALMED DOWN¿ SINCE 3PM ON THE DAY OF THIS REPORT. THE REPORTER STATED ¿RIGHT NOW MY VAGINA FEELS FUNNY SO WHAT¿S GOING ON?¿ IT WAS FURTHER NOTED, THE PATIENT HAD NO FALLS OR TRAUMA, BUT DID DO SOME STRETCHES THE MORNING OF THIS REPORT. IT WAS NOTED PATIENT CHANGED THEIR BATTERIES IN THE PATIENT PROGRAMMER. THE REPORTER INQUIRED IF THEIR PAIN MAY GO AWAY IF THEY TURN STIMULATION DOWN OR OFF. IT WAS REPORTED, THE PATIENT WAS ON PROGRAM 2 AT 0.7 AND DECREASED THE STIMULATION TO 0.6. ADDITIONAL INFORMATION RECEIVED REPORTED, THE PATIENT RECEIVED ASSISTANCE FROM THEIR DOCTOR OR MANUFACTURING REPRESENTATIVE AND THEIR CONCERNS WERE RESOLVED. ADDITIONAL INFORMATION WAS REQUESTED, BUT WAS NOT AVAILABLE AS OF THE DATE OF THIS REPORT.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION RECEIVED REPORTED THAT THE PATIENT WAS HAVING PAIN THAT INITIALLY STARTED THE LAST TIME THE PATIENT ASKED FOR HELP TO DECREASE STIMULATION. IT WAS NOTED THAT THE PAIN SUBSIDED. THE REPORTER STATED THAT CURRENTLY THE PATIENT CONTINUED TO HAVE PAIN THAT MOVED AROUND BETWEEN THE IMPLANT AND SPINE-SCIATIC NERVE AND THE PAIN WAS WORSE WHEN THE PATIENT WAS SITTING. IT WAS NOTED THAT THE PAIN WAS BETTER WHEN THE PATIENT WAS UP AND AMBULATING. THE PATIENT'S PROGRAM WAS CHANGED FROM PROGRAM 2 AT 0.6 VOLTS TO PROGRAM 3 AT 0.5 VOLTS. IT WAS REPORTED THAT THE PATIENT WANTED TO KNOW WHEN CHANGE WOULD HELP HER PAIN AND "CHANGE HER BODY." IT WAS NOTED THAT THE LAST TIME THE PATIENT CALLED WAS AFTER SHE HAD BEEN LAYING/SITTING ON A SOFT SOFA FOR TWO MONTHS AND SHE STRUGGLED WHEN TRYING TO GET UP FROM THE SOFA. IT WAS REPORTED THAT WHEN THE PATIENT GOT UP FROM THE SOFA WAS WHEN THE IMPLANT WAS "POUNDING" AND THE PATIENT WANTED HELP DECREASING STIMULATION. IT WAS NOTED THAT WITHIN A FEW HOURS THE THROBBING STOPPED. IT WAS LATER REPORTED THAT THE PATIENT FELT A BURNING SENSATION AFTER BEING ON PROGRAM 3. IT WAS NOTED THAT THE PATIENT WAS STILL HAVING PROBLEMS WITH BURNING AND ACHING AND IT WAS SOMETIMES IN THE HIPS AND SOMETIMES IT WENT DOWN THE LEGS A LITTLE AND THEN STOPPED. IT THEN WENT INTO THE LOWER SPINE "BURNING." THE REPORTER STATED THAT THE PATIENT MAY NEED TO CHANGE TO PROGRAM 4. IT WAS REPORTED THAT THE PATIENT HAD NOT SEEN THE DOCTOR BUT WAS GOING TO MAKE AN APPOINTMENT SINCE THE "LAST CHANGE" DID NOT IMPROVE THE SYMPTOMS. IT WAS NOTED THAT THE PATIENT MENTIONED LOWERING STIMULATION AND THOUGHT THAT IT WAS IRRITATING HER SPINE AND "MOSTLY BURNING IN THE SPINE. IT WAS REPORTED THAT SINCE IMPLANT THE PATIENT HAD GONE THROUGH PROGRAMS 1, 2, AND 3 AND THE PATIENT ONLY CHANGED PROGRAMS WHEN CALLING A MANUFACTURER REPRESENTATIVE BECAUSE SHE WAS "NOT SURE HOW TO WORK IT." IT WAS NOTED THAT THE FIRST SETTING WAS ALRIGHT EXCEPT IT WAS VIBRATING IN THE PATIENT'S VAGINA, BUT DIDN'T CAUSE HER BACK PAIN. IT WAS NOTED THAT THE VIBRATING WAS IRRITATING SO THE PATIENT CHANGED TO PROGRAM 2. THE REPORTER STATED THAT THE LAST TIME THEY CALLED A MANUFACTURER REPRESENTATIVE THE PATIENT WAS "PUT ON 5 AND THE NEXT DAY SHE "PUT IT ON 6" BUT WAS TRYING TO "GET AWAY FROM THE SPINE THING" AND WAS NOW AT 3.6. THE PATIENT SWITCHED TO PROGRAM 4 AND FELT VIBRATION AT 0.3, WENT BACK TO 0.1 AND "FELT SOMETHING BACK THERE." THE PATIENT WAS AT 0.1 AND FELT "SOMETHING IN HER BUTTOCKS THAT SHE DIDN'T FEEL BEFORE. THE PATIENT WENT BACK TO PROGRAM 3 AND THEN TRIED PROGRAM 4 AND IT WAS IRRITATING HER. IT WAS REPORTED THAT THE PATIENT WENT TO PROGRAM 1 WHERE SHE "HAD THE VAGINA TAPPING" AND THE PROGRAM WAS SET AT 1.4. IT WAS NOTED THAT PROGRAM 1 AT 1.7 "WAS HARSH" AND THE PATIENT WENT TO 1.6 THE SAME DAY BUT "IT STARTED WITH THE VAGINA A FEW WEEKS LATER. IT WAS REPORTED THAT PROGRAM 1 WAS IRRITATING LIKE PROGRAM 4 WAS, AND THE PATIENT TRIED 1.0 AND 1.1 AND THOUGHT IT WAS BETTER FOR NOW AND WOULD LEAVE IT ON THAT SETTING FOR SEVERAL DAYS. IT WAS NOTED THAT THE PATIENT HAD NOT TALKED TO THE DOCTOR'S OFFICE SINCE (B)(6) AND AT THAT TIME THE PAIN HAD GONE AWAY. IT WAS REPORTED THAT THE PATIENT HAD NOT TURNED THE DEVICE OFF SINCE SURGERY. THE REPORTER STATED THAT THE DEVICE WAS HELPING AND THE PATIENT WAS DOWN TO TWO CATHETERS A DAY, AND BEFORE THE DEVICE IT WAS FOURTEEN A DAY. IT WAS REPORTED THAT "IT WAS QUIETING DOWN" WHILE THE PATIENT WAS SITTING THERE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    342458 INTERSTIM II STIMULATOR, ELECTRICAL, IMPLANTABLE, FOR INCONTINENCE EZW MEDTRONIC MED REL MEDTRONIC PUERTO RICO 3058

    Patients

    Seq Age Sex Outcome Treatment
    1 00074 YR Required Intervention